The FDA, part 2

Amber Wheat

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The Food and Drug Administration is responsible for a wide range of products, but the one people think of most often is prescription drugs. As I said in my earlier post, the FDA was originally created to protect the public from products that claimed to do something it didn’t (like cure cancer, or whatnot). The FDA demanded truthful labeling and wouldn’t allow companies to say their product had a certain effect if the company couldn’t prove in clinical trials that the product really did do that.

Something that has always bothered me about medications on the market today are the side effects. At the end of the very nice commercial with people walking on the beach and getting the most out of their lives, a very quick, professional voice speaks over the picture. This disembodied voice warns of complications like “death and cancer may occur”. Death may occur? Really? Why is this medication even allowed if death may occur? Isn’t the FDA supposed to protect us from death occurring?

The answer is... kind of. The FDA knows that the product has nasty side effects, but because the maker warns us of them, it becomes our own choice to take that risk. If people living with fibromyalgia or any other condition that causes them to have to live with daily pain choose to take these medications to alleviate some of their suffering, the FDA lets them make that choice.

When decided whether or not to let a new drug into the market, the FDA looks at the benefits of the drug balanced against the risks. Remember, the FDA doesn’t do their own testing. They make their decisions based on the manufacturer’s clinical studies. It is hard to say what is worth the risk of death. I don’t live with rheumatoid arthritis or fibromyalgia or any other condition that causes people a great deal of pain, so I don’t have to make a choice like that.

It just seems like the FDA doesn’t do much to protect the public. Of course, if it was the government’s responsibility to protect people from themselves we wouldn’t have nearly as much freedom as we do now. But rules like the prohibition of releasing information on drugs that are under review by the FDA seems counterproductive. Yes, you want to preserve the privacy (and profits) of the company making the drug, but in the meantime, the public is still buying and taking the drug that, for some reason, the FDA felt the need to review. What is wrong with it? Why is it being reviewed? Should I stop taking it? Don’t we have a right to know these things?

What do you think?

Read Part 3